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Atorvastatin Calcium

CAS number: 134523-03-8

Molecular formula: C66H68CaF2N4O10

molecular weight: 1155.36

Chemical structure:

Producers shown on SFDA

(Record date:01/09/2021)

Producer

Documents

GMP Valid till(based on SFDA)

Zhejiang Haisen Pharmaceutical Co., Ltd.

GMP 
Valid till August 2021

Zhejiang Lepu Pharmaceutical Co., Ltd.

GMP, DMF
Valid till February 2024

Zhejiang Hongyuan Pharmaceutical Co., Ltd.

GMP, DMF
Valid till March 2023

Shijiazhuang Pharmaceutical Group Huasheng Pharmaceutical Co., Ltd

GMP 
Valid till February 2018

Tianjin Jialin Medical Co., Ltd.

GMP 
Valid till July 2023

Wuhan Zy Pharmaceutical Co., Ltd.

GMP 
Valid till January 2019

Zhejiang Jiangbei Pharmaceutical Co., Ltd.

GMP 
Valid till November 2024

Hunan Dino Pharmaceutical Co., Ltd.

GMP 
Valid till May 2021

Zhejiang Hisun Pharmaceutical Co., Ltd. 

GMP 
Valid till  April 2022

Beijing Jialin Pharmaceutical Co., Ltd.

GMP 
Valid till December 2017
Jiangsu Hengrui Medicine Co.,Ltd.
GMP 
Valid till November 2020

Topfond Pharmaceutical Co., Ltd.

GMP 
Valid till December 2020



Producers shown on EP

(Quoted from EP website;record date:01/09/2021)

Substance
Certificate Holder
Certificate Number
Issue  Date
Status
End date
Type
Atorvastatin calcium trihydrate Form-I
DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad
  R1-CEP 2011-222-Rev 00
04/06/2020
VALID
/Chemistry
Atorvastatin calcium trihydrate
Changzhou Pharmaceutical Factory CN 213 018 Jiangsu Province
  R0-CEP 2015-034-Rev 01
17/01/2017
VALID
/Chemistry
Atorvastatin calcium trihydrate Form I, ATN process
DR. REDDY'S LABORATORIES LIMITED IN 500 034 Hyderabad
  R0-CEP 2020-092-Rev 00
01/10/2020
VALID
/Chemistry
Atorvastatin calcium trihydrate
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R1-CEP 2012-035-Rev 00
19/07/2019
VALID
/Chemistry
Atorvastatin calcium trihydrate
MSN PHARMACHEM PRIVATE LIMITED IN 502 307 Pashamylaram Village
  R1-CEP 2011-068-Rev 01
22/02/2018
VALID
/Chemistry
Atorvastatin calcium trihydrate Process-IV
CADILA HEALTHCARE LIMITED IN 393 002 Ankleshwar
  R0-CEP 2021-079-Rev 00
05/07/2021
VALID
/Chemistry
Atorvastatin calcium trihydrate
AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad
  R1-CEP 2011-013-Rev 00
29/09/2017
VALID
/Chemistry
Atorvastatin calcium trihydrate
HEC PHARM GMBH DE 10963 Berlin
  R0-CEP 2012-382-Rev 01
23/11/2015
WITHDRAWN BY HOLDER
30/10/2017
Chemistry
Atorvastatin calcium trihydrate Micronised
MOREPEN LABORATORIES LIMITED IN 110 001 New Delhi
  R1-CEP 2012-179-Rev 03
21/05/2021
VALID
/Chemistry
Atorvastatin calcium trihydrate
Zhejiang Hisun Pharmaceutical Co., Ltd. CN 318 000 Taizhou City
  R0-CEP 2013-339-Rev 00
19/11/2014
WITHDRAWN BY HOLDER
15/10/2020
Chemistry
Atorvastatin calcium trihydrate
ZHEJIANG JIANGBEI PHARMACEUTICAL CO., LTD. CN 318 017 Taizhou City
  R1-CEP 2014-160-Rev 00
25/03/2021
VALID
/Chemistry
Atorvastatin calcium trihydrate
KRKA d.d. SI 8501 Novo Mesto
  R1-CEP 2013-024-Rev 01
28/05/2020
VALID
/Chemistry
Atorvastatin calcium trihydrate
SANECA PHARMACEUTICALS A.S. SK 920 27 Hlohovec
  R0-CEP 2015-271-Rev 00
28/06/2017
VALID
/Chemistry
Atorvastatin calcium trihydrate Crystalline
BIOCON LIMITED IN 560 100 Bengaluru
  R1-CEP 2011-009-Rev 02
22/04/2021
VALID
/Chemistry
Atorvastatin calcium trihydrate Process II
CADILA HEALTHCARE LIMITED IN 393 002 Ankleshwar
  R1-CEP 2011-156-Rev 03
31/03/2020
VALID
/Chemistry
Atorvastatin calcium trihydrate
ZHEJIANG LEPU PHARMACEUTICAL CO.,LTD CN 318 000 Taizhou City
  R1-CEP 2012-139-Rev 01
31/08/2020
VALID
/Chemistry
Atorvastatin calcium trihydrate
AMOLI ORGANICS PRIVATE LIMITED IN 400 021 Mumbai
  R1-CEP 2014-206-Rev 00
09/06/2021
VALID
/Chemistry
Atorvastatin calcium trihydrate Process I
CADILA HEALTHCARE LIMITED IN 393 002 Ankleshwar
  R1-CEP 2011-181-Rev 01
02/03/2018
VALID
/Chemistry
Atorvastatin calcium trihydrate
MYLAN LABORATORIES LIMITED IN 500 034 Hyderabad
  R1-CEP 2011-184-Rev 01
16/06/2017
VALID
/Chemistry
Atorvastatin calcium trihydrate
CENTRIENT PHARMACEUTICALS NETHERLANDS B.V. NL 2613 AX Delft
  R1-CEP 2010-366-Rev 03
16/06/2021
VALID
/Chemistry
Atorvastatin calcium trihydrate
LUPIN LIMITED IN 400 055 Mumbai
  R0-CEP 2014-145-Rev 02
10/12/2020
VALID/Chemistry
Atorvastatin calcium trihydrate Process-III
CADILA HEALTHCARE LIMITED IN 393 002 Ankleshwar
  R0-CEP 2020-309-Rev 00
19/02/2021
VALID
/Chemistry
Atorvastatin calcium trihydrate AS
TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva
  R0-CEP 2018-059-Rev 01
12/12/2019
VALID
/Chemistry
Atorvastatin calcium trihydrate
Ind-Swift Laboratories Limited IN 160 101 Chandigarh
  R1-CEP 2011-234-Rev 02
12/05/2020
VALID
/Chemistry
Atorvastatin calcium trihydrate Form-I
HETERO LABS LIMITED IN 500 018 Hyderabad
  R0-CEP 2018-049-Rev 00
02/04/2020
VALID
/Chemistry
Atorvastatin calcium trihydrate
NINGBO MENOVO PHARMACEUTICAL CO., LTD. CN 315 040 Ningbo Hi-Tech District
  R0-CEP 2019-013-Rev 00
24/09/2020
VALID
/Chemistry
Atorvastatin calcium trihydrate Process-IV
SUN PHARMACEUTICAL INDUSTRIES LIMITED IN 400 063 Mumbai
  R1-CEP 2013-094-Rev 01
25/02/2021
VALID
/Chemistry
Atorvastatin calcium trihydrate Process II
Ind-Swift Laboratories Limited IN 160 101 Chandigarh
  R0-CEP 2021-102-Rev 00
25/06/2021
VALID
/Chemistry
Atorvastatin calcium trihydrate
CHROMO LABORATORIES INDIA PRIVATE LIMITED IN 502 307 Pashamylaram
  R0-CEP 2015-288-Rev 02
08/07/2021
VALID
/Chemistry
Atorvastatin calcium trihydrate
ZHEJIANG HONGYUAN PHARMACEUTICAL CO., LTD. CN 317 016 Duqiao
  R0-CEP 2017-158-Rev 01
13/08/2021
VALID
/Chemistry

Producer:Zhejiang Haisen Pharmaceutical Co., Ltd., located in Liushi street, Dongyang City, is a national high-tech enterprise engaged in the R & D, production and operation of APIs and pharmaceutical intermediates. The company covers an area of 70000 square meters and has more than 400 employees, including professional technicians   More than 30%.

The company passed ISO9001:2000 international quality system certification in 2001. It passed the domestic GMP certification for the first time in 2006, obtained the EU CEP Certificate in the same year, and passed the on-site audit of FDA for the first time in 2014. At present, many varieties have been registered in the United States, the European Union, Japan, South Korea, India, Brazil, Mexico and other countries. Among them, sucralfate products account for more than 60% of the world market.

Staff size:400-499 persons

Registered capital:RMB 51 million


Producer:Zhejiang Lepu Pharmaceutical Co., Ltd., established in 2001, is located in Jiaojiang block, Taizhou chemical API Industrial Park, Zhejiang Province. Covering an area of nearly 300 mu, the company is a core subsidiary of Lepu (Beijing) medical device company.

The company attaches great importance to product quality and has successively passed GMP certification and registration such as China nm-pa, US FDA, EU EDQM, Japan PMDA and Korea KFDA. Many varieties occupy a leading position in the world.

The company's marketing network covers five continents and has established partnerships with nearly 600 customers at home and abroad in more than 70 countries and regions. Many products lead the sales in the international market, among which the sales of main varieties of atorvastatin calcium account for more than 50% of the world.

Staff size:700-799 persons

Registered capital:RMB 160 million


Producer:Zhejiang Hongyuan Pharmaceutical Co., Ltd., established in 2005, is a member of Zhongda Group Co., Ltd., one of the world's top 500 enterprises, and a holding subsidiary of Wuchang Chemical Group Co., Ltd.

The company has an experienced management team, has established a relatively standardized and perfect quality management system and EHS management system, and has passed the acceptance of national GMP certification, standardization certification, cleaner production, three Simultaneities and professional control evaluation.

Staff size:300-399 persons

Registered capital:RMB 29.5 million


Producer:The company has been cancelled

Staff size:/

Registered capital:RMB 4 million


Producer:Tianjin Jialin Pharmaceutical Co., Ltd., established on September 7, 2011, is subordinate to Beijing Jialin Pharmaceutical Co., Ltd.

Staff size:100-199 persons

Registered capital:RMB 100 million


Producer:Wuhan Zy Pharmaceutical Co., Ltd., established in April 2009 and located in Gedian Economic and Technological Development Zone, Ezhou City, Hubei Province, is a modern generic drug R & D and API production enterprise in line with FDA and cGMP. The investment in phase I is RMB 300 million, covering an area of 172 Mu and phase II is 200 mu, totaling 372 mu. In October 2013, it obtained the drug production license of Wuhan Zhongyou Pharmaceutical Co., Ltd. and successfully obtained the 2010 GMP certificate of atorvastatin calcium and fasudil mesylate. It is an export-oriented high-end pharmaceutical raw material production base based on the EHS requirements of ISO and OSHA and the cGMP standards of FDA and EU, and will be subject to the official cGMP inspection of FDA and EU. At present, it has been successfully exported to the United States, Europe, India and other international markets.
Staff size:100-199 persons

Registered capital:RMB 30 million


Producer:Zhejiang Jiangbei Pharmaceutical Co., Ltd., founded in July 1993, is a private enterprise focusing on the production of APIs, intermediates and solid preparations. At present, simvastatin, atorvastatin and levetiracetam have successively passed the official inspection and certification of FDA, CEP, who, Japan, South Korea and India, and passed the new version of GMP inspection in China.
Staff size:300-399 persons

Registered capital:36 million 124 thousand and 417


Producer:Hunan Dino Pharmaceutical Co., Ltd., founded in 1997, formerly from Hunan Pharmaceutical Industry Research Institute, is a modern growth high-tech enterprise engaged in the production and marketing of medicine and raw materials.   At present, the company has two GMP certified modern pharmaceutical bases in Liuyang and Changsha, including more than ten dosage forms and 14 production lines, such as tablets, capsules, ointments, dry suspensions, pellets, small volume injections, chemical synthetic APIs and oral liquids. Strictly control "quality" and establish a quality assurance system in line with international quality supervision concepts such as FDA, ICH and EDQM.

Staff size:800-899 persons
Registered capital:RMB 17.876059 million


Producer:Zhejiang Hisun Pharmaceutical Co., Ltd. was founded in 1956. In 2000, Hisun issued A-shares in Shanghai stock exchange, but it continues to remain a state-owned enterprise. Hisun is one of the largest antibiotics and anti-tumor drug production bases in the country. It has won several titles, including first batch of innovative enterprises, national technology innovation demonstration enterprises, and "National Industrial Brand Demonstration Enterprise” of the Chinese Ministry of Industry and Information Technology. 

Hisun began as a small chemical factory and entered the pharmaceutical field in the early 1970s. Since its founding over 60 years ago in 1956, Hisun has amassed a total asset worth of 21.8 billion RMB. While Hisun is primarily engaged in the R&D, manufacturing, and sales and marking of API and final dosage forms of chemical and biological drugs, its core business has extended to include branded generic drugs, biosimilarst and other innovative drugs. 

Staff size:About 9000 persns

Registered capital:RMB 1 billion 169 million


Producer:Beijing Jialin Pharmaceutical Co., Ltd., established in December 1998, is a high-tech enterprise appointed by Beijing Science and Technology Commission and a wholly-owned subsidiary of dezhanda health Co., Ltd.

The company has invested more than 50 million yuan to build an oral solid preparation workshop, antitumor drug workshop, fine drying charter room, drug warehouse supporting production and scientific research, central laboratory and inspection center in line with the national GMP standard on the basis of the original plant. The plant covers an area of 41021 square meters and a construction area of 12170 square meters. Annual production capacity: 700 million tablets; 200 million capsules; 5 million bags of granules; 90000 tons of raw materials. The enterprise has increased the software and hardware construction of the production quality system and passed the national GMP certification.

Staff size:400-499 persons

Registered capital:RMB 30.5 million


Producer:Jiangsu Hengrui Medicine Co.,Ltd. is a pharmaceutical company engaged in the development and commercialization of innovative and high-quality drugs. 

The company has 28000 employees globally, fifth R & D centers were built around the globe and several subsidiaries were established in the US, EU, and Japan

The company has 10 manufacturing facilities and most of them maintain USP, EUP, and JP. We are the first Chinese company that exported injections on a large scale to the US, EU, and Japan markets. All dosage forms of the company have passed the national GMP certification, and ifosfamide, etoposide, mesilar and tiotepa have passed the verification of FDA.

Staff size:About 30000 persons

Registered capital:RMB 6 billion 397 million


Producer:Topfond Pharmaceutical Co., Ltd.is a large-scale large-scale enterprise integrating the production and sales of finished products, chemical synthesis raw materials and biological fermentation raw materials, and pharmaceutical management. Comprehensive pharmaceutical company.

Topfond Pharmaceutical was founded in 1969. In December 2000, the A shares of Topfond  Pharmaceutical was listed on the Shanghai Stock Exchange. After more than 40 years of hard work, the company has grown from small to large, from weak to strong, and has now developed into a large pharmaceutical group with 5 subsidiaries, 4 production plants and 1 national technology development center. It has 4000 employees. There are more than 4 people with total assets of more than 4 billion yuan. The company's production scale of finished preparations and fermentation tonnage of antibiotic raw materials are among the best in the industry in the country. Joined China General Technology Group in August 2008. In July 2013, it successfully realized the merger and absorption of shares exchange with China National Pharmaceutical and Health Industry Co., Ltd., and was officially included in China Pharmaceutical Management.

Topfond Pharmaceutical produces and reserves more than 10 types and nearly 600 varieties and specifications of products. It has an oral solid preparation workshop with an annual production capacity of nearly 6 billion tablets (tablets), the scale is among the forefront of the industry; the antibiotic fermentation tonnage is 12,000m³. The raw materials and some preparation products are exported to more than 20 countries and regions including Western Europe, Southeast Asia, the Middle East, North Africa, India, etc., and an international marketing network is initially formed.

Staff size:2000-2999 persons

Registered capital:RMB 420 million


For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978